Predicted Level of General Anaesthesia in Hip Fracture Surgery (NAPfem)

The purpose of this study is to evaluate if prediction of general anaesthesia level by the Smartpilot® View device can improve the quality of anaesthesia in patients undergoing hip fracture surgery.

Study Overview

• Status: Completed
• Conditions: Hip Fracture Surgery
• Intervention / Treatment: Device: General anesthesia managed by the Smartpilot® View; Device: General anesthesia managed without the Smartpilot® View

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • University Hospital Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient undergoing hip fracture surgery under general anaesthesia
• Age ≥ 18 years old
• ASA classification 1, 2 or 3

Exclusion Criteria:

• Patient not insured by a social security scheme
• Adult patient under tutorship or curatorship
• Age over 18 years old or under 90 years old
• Weight under 40 or over 140 kilos and/or height under 150 or over 200 cm
• Body mass index > 35
• Contraindication to one or more anaesthetics used in the study
• Pregnancy or breastfeeding
• Unweaned alcoholism
• ASA classification 4 or 5
• Patient undergoing hip fracture surgery under spinal anaesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smartpilot View group; General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.	Device: General anesthesia managed by the Smartpilot® View; General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.
Active Comparator: Control group; General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.	Device: General anesthesia managed without the Smartpilot® View; General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time spent in the "appropriate anaesthesia zone"	The "appropriate anaesthesia zone" is defined as a bispectral index between 45 and 65 and a systolic blood pressure between 80 and 140 mmHg	participants will be followed for the duration anesthesia, an expected average of 5 hours (from intubation to recovery) for hip fracture surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Dose of propofol	participants will be followed for the duration anesthesia, an expected average of 5 hours
Dose of sufentanil	participants will be followed for the duration anesthesia, an expected average of 5 hours
Time to extubation	end of anaesthesia
"NASA Task Load Index"	participants will be followed for the duration anesthesia, an expected average of 5 hours
Morphine consumption	participants will be followed for the duration in recovery room, an expected average of 24 hours
Incidence of awareness with recall during anaesthesia	postoperative day 1
"Postoperative Quality Recovery Scale"	during recovery room (an expected average of 24 hours) and postoperative days 1 and 3
Length of stay	postoperative day 30
Mortality	postoperative day 30

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Mathieu CONTE, M.D., University Hospital, Angers

Publications and helpful links

General Publications

• Leblanc D, Conte M, Masson G, Richard F, Jeanneteau A, Bouhours G, Chretien JM, Rony L, Rineau E, Lasocki S. SmartPilot(R) view-guided anaesthesia improves postoperative outcomes in hip fracture surgery: a randomized blinded controlled study. Br J Anaesth. 2017 Nov 1;119(5):1022-1029. doi: 10.1093/bja/aex317.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 21, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 22, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 15, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Intraoperative hypotension; Hip fracture surgery; Depth of anaesthesia; Smartpilot View; Quality of anaesthesia
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2014-A01243-44